Orthopaedic gel pad assembly

ABSTRACT

An orthopaedic gel pad assembly includes a layer of gel, with a backing layer behind it, an apertured pad extending around the layer of gel and a thin plastic film extending over the front surface of the gel. The plastic film controls the configuration of the front face of the gel, and the gel may be recessed, or indented, and may protrude forwardly out from the apertured pad. Stiff orthopaedic supports may be provided to back up the gel pad unit.

This application is a continuation of U.S. patent application Ser. No.07/987,622 filed Dec. 12, 1992, now abandoned, which is a reissue ofU.S. patent application Ser. No. 07/470,140 filed Jan. 25, 1990, nowU.S. Pat. No. 5,027,801. .Iaddend.

RELATED PATENT APPLICATIONS

Attention is directed to U.S. patent application Ser. No. 055,711, filedMay 29, 1987, now U.S. Pat. No. 4,844,094, granted July 4, 1989,entitled "Ankle Brace" and assigned to the assignee of this application;and to U.S. patent application Ser. No. 168,681, filed Mar. 16, 1988,now U.S. Pat. No. 4,913,755, granted Apr. 3, 1990 and also assigned tothe assignee of this application. This patent application is acontinuation-in-part of the foregoing two patent applications.

BACKGROUND OF THE INVENTION

After injury to an ankle, such as a fracture or severe ankle sprain, itmay be necessary to completely immobilize the ankle through the use of amolded plaster or resin cast. However, once the injury has beenstabilized, recovery may be hastened by removing the molded plaster orresin cast and using a removable functional walking brace so that theankle can be exercised during healing.

An important element of these functional walking braces is the linerelement that provides a resilient support against the sides of theankle. The liner helps stabilize the ankle against inversion andeversion while still permitting the normal dorsi-flexion andplantar-flexion movement of the; ankle. It has previously been proposedto form such pads of foam rubber, or using inflatable bags.

One such proposed prior ankle brace using an air-inflatable liner isshown in prior U.S. Pat. No. 4,280,489 listing Glen W. Johnson, Jr. asthe inventor. Although the air-inflatable liner provides some resilientsupport against the ankle, it suffers from the following disadvantages.One disadvantage is that the air is unduly buoyant, and permits rapidmovement of the air from one side to another, so that adequate supportis not provided. Further, with air inflatable bladders, a puncturerenders the braces inoperative and dangerous to the user as the outerrigid plastic shells could cut or rub the wearer.

The use of foam rubber pads, as exposed liners in walking braces isdisclosed in U.S. Pat. No. 4,572,169 listing Mauldin and Jones asinventors. The use of foam rubber has significant disadvantages in thatthe foam rubber is U.V. sensitive, and tends to deteriorate afterexposure a certain period of time. Further, the foam does not tend toconform to the configuration of the ankle joint, but bounces back to itsoriginal configuration. Also, neither air filled cushioning arrangementsnor foam are suitable for hot and cold temperature therapy.

Attention is also directed to W. R. Spence U.S. Pat. No. 3,548,420granted Dec. 11, 1970, which discloses the use of gel in a "CushionStructure", but not in combination with a thin enclosing plastic layer.

Accordingly, the objects of this invention include providing anorthopaedic brace or support that provides resilient support and is freefrom adverse effects of puncturing, forms a relatively stable pad,conforms to the configuration of the ankle, has a high thermal capacity,has well defined boundaries, has homogeneous thickness throughout itslength and width, and is very comfortable when used for therapeuticheating or chilling of the injured leg, and has good long term hot andcold therapy properties.

SUMMARY OF THE INVENTION

The present invention is directed to a method and an apparatus forforming gel-filled cushion pads that provide a resilient support againstthe ankle. The apparatus includes, among other elements, a vacuumchamber that is substantially enclosed except at the top. A perforatedplate having many drilled, small holes on its surface is used to coverthe top portion of the vacuum chamber. The vacuum chamber also includesa channel for connecting it to a vacuum pump. A vacuum pump is used towithdraw the air from the vacuum chamber.

A spacer pad, normally made of foam rubber is then laid over theperforated plate. The spacer pad normally includes one or more openingson its surface. Each of these openings provide for a space that has theperforated base plate as its base and has a depth equal to the thicknessof the spacer pad. Further, the walls of this space have the pattern ofthe corresponding opening on the surface of spacer pad.

The present invention also includes a front aperture pad that isnormally made of rubber foam, and overlies the space pad. The frontaperture pad also has openings on its surface that normally have thesame pattern as the openings on the surface of the spacer pad. The frontaperture pad is normally laid over on the spacer pad such that theseopenings on the spacer pad are in alignment with openings on the spacerpad on that pad. With the openings on the aperture pad and spacer padaligned, a laterally enclosed space is formed. This space is laterallyconfined at the bottom by the perforated base plate, and is laterallyconfined by the inner walls of the spacer pad and front pad. The depthof this space is substantially equal to the sum of one thickness of thespacer pad and one thickness of the front pad. This space, hereinaftercalled "the gel-space" is used for storing the liquid gel for thesolidification process.

Another element of the apparatus is a thin plastic film which may, forexample, be made of urethane. With the front pad in alignment with thespacer pad, an adhesive coating is located on the upper surface of thefront pad and a thin film of urethane is laid over the front pad. Then,the vacuum pump is turned on, causing air to be drawn from the vacuumchamber. The fine perforations through the base plate extend to thealigned openings in the two pads within the periphery of these openings.As a result, a stream of air flows into the vacuum chamber through theexposed holes on the surface of the perforated base plate. The inflow ofair through these holes causes the thin film to be drawn towards theperforated plate tightly and neatly particularly around the edges of thegel-receiving openings. Concurrently with this vacuuming process, aheating device is used to raise the temperature of the thin film andthereby cause it to expand and snugly cover the exposed base plate aswell as the walls of the gel-space. After the heating process, the thinfilm substantially forms the boundaries of the gel-space. Apredetermined amount of the gel is then mixed so that it will solidifyin a few minutes, and is poured into the gel-space, on top of the thinfilm, and allowed to solidify for a few minutes. The predeterminedamount of gel is measured to substantially fill the gel-space. Thevacuum process may continue while the liquid gel is being poured intothe gel-space to make sure that the thin film will not be substantiallydisplaced.

After the gel has solidified, an adhesive coated back pad, normally madeof foam rubber, is laid over on top of the thin plastic film.

With this process, a solid, dense layer of gel is confined between theback pad on the top and the thin film at the bottom, with the thin filmbeing secured to the inner walls of the spacer pad and front pad. Eachone of the gel filled gel-spaces constitutes a gel pad unit. Sinceseveral contiguous gel-spaces may be formed by overlying the front padon the spacer pad, the above process may involve formation of severalcontiguous gel pad units

Since a number of contiguous gel pad units my be formed concurrentlyduring the above process, these gel pad units my be cut out to form asingle unit Each individual unit of these gel cushion pads or linen maythen be used in walking braces for providing a resilient support againstthe ankle. By using these gel linen for each walking brace, multipleadvantages are realized.

First, a gel cushion pad may be repeatedly punctured with no adverseeffect, as the gel seals itself and does not leak out. Further these gelliners form a relatively stable pad in which the gel does shift inposition somewhat to conform to the configuration of the ankle bone, butdoes not migrate more than about one-quarter or one inch.

In addition, gel liners produced by the method of the present inventionhave n well defined boundary and homogeneous thickness throughout thelength and width of the gel pad. Further, since the gel pad covers onlythe injured part of the leg, the rest of the leg will not beunnecessarily affected by the heat and cold therapeutic treatmentreceived by the injured part of the leg.

It is further noted that the gel pads may be formed by the method of thepresent invention, using a somewhat thicker spacer pad, and having abacking in the form of an additional urethane film or layer, heat sealedor adhered to the underlying urethane layer to form a simple urethanefilm covered layer, similar to that shown in the prior copending patentapplication cited hereinabove.

In accordance with another aspect of the invention, an orthopaedicassembly includes a gel pad employed in combination with stiffsupporting arrangements for splinting a bone or joint, with the gel padbeing secured to the stiff supporting arrangements to match theirregular and individual configuration of the joint or bone to which theorthopaedic assembly is to be secured. These arrangements are applicableto the wrist, knee, and other bones or joints, as well as to the ankle.

The combination of gel, an inner protective plastic film, and a backinglayer, which may, for example, be formed of foam rubber, providesexcellent overall properties for use with a brace or support, with thegel pad adjacent the injured area, such as a joint, to conform thereto,and the foam rubber providing resilient support, and also having goodthermal insulation properties when the gel is heated or cooled toprovide hot or cold therapy. Further, the inner film protects the gelfrom contamination and the user's body from the stickiness of the gel.Also, the inner film permits configuration of the gel to the desiredcontour or shape, with gel-free spaces to permit easy flexing of thepad, or reduced thickness gel areas to accommodate protruding bonestructures, such as the malleolus.

Other objects, features, and advantages of the invention will becomeapparent from n consideration of the following detailed description andfrom the accompanying drawings

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view of an apparatus for forming gel-filledcushion pad or liners, illustrating the principles of the invention;

FIG. 2 is a partial cross-sectional side view of the apparatus of FIG. 1further illustrating the formation of the gel-pads;

FIG. 3 is a top view of the finished product that includes threecontiguous units of gel pad liners; FIG. 4 is a top view of anindividual gel-pad unit that is cut out of the finished product shown inFIG. 3.

FIG. 5 is a cross-sectional view taken along the line 5--5 of FIG. 4,illustrating the back pad, front aperture pad, and the semi-solid gellayer;

FIG. 6 is a side view of the get pad of FIG. 4, illustrating the mannerin which the gel pad is confined to the back pad, and inner walls of thefront pad;

FIG. 7 is a perspective view of a walking brace assembly, illustratingthe manner in which the individual units of gel-pads are used in thewalking brace;

FIG. 8 illustrates the manner in which the gel pads and the walkingbrace support the ankle;

FIG. 9 illustrates the manner in which the straps on a walking brace areused to provide a firm grip around the leg, with the gel padsresiliently supporting the ankle;

FIG. 10 shows a modified form of the pad shown in FIGS. 4 through 6;

FIG. 11 is a cross-sectional view taken along line 11--11 of FIG. 10;

FIG. 12 is a perspective view of a gel pad which may be used with a neckbrace or support;

FIG. 13 is a cross-sectional view taken along line 13--13 of FIG. 12;and

FIG. 14 shows the gel pad of FIGS. 12 and 13 in use with a neck brace.

DETAILED DESCRIPTION

Referring more particularly to the drawings, FIG. 1 is a cross-sectionalview of an apparatus 12 for forming gel liners, illustrating certainprinciples of the invention. As shown, the apparatus includes a vacuumchamber 14 that is substantially enclosed, except at the bottomopening-channel 18 and the top opening. Vacuum chamber 14 is connectedto a vacuum pump 16 using the channel 18. When the vacuum pump 16 isturned on, the air is drawn through channel 18, out of chamber 14. Theopening at the top of the chamber 14 is substantially covered by aperforated plate base 20 having a number of drilled holes on itssurface. In this manner, the vacuum created in the chamber 14, causesstreams of air to flow into the chamber 14 through the fine holesextending through the surface of the perforated plate base 20.

The apparatus also includes a spacer pad 22 which overlies theperforated base plate 20. Spacer pad 22 is relatively thin, and may havea thickness of about 3 milllmeters. The spacer pad 22 may be made ofrubber foam material. As shown in FIG. 3, the spacer pad 22 may havethree patterned openings, each used for forming an individual andcontiguous unit of gel-filled cushion pad. As shown in FIG. 1, a frontaperture pad 24 overlies spacer pad 22. Normally, spacer pad 22 and thefrom pad 24 include substantially similar and aligned patterned openingson their surface. This is better illustrated in FIG. 3 showingsubstantially similar patterned openings on the surface of spacer pad 22and front pad 24. Thus, by overlying front pad 24 on spacer pad 22 insuch a way that the patterned opening of the front pad 24 and spacer pad22 are in alignment, several "gel-pockets" or "gel-spaces" are formed,such as gel-pocket 27.

The gel-pocket 27 is enclosed laterally by the inner walls of front pad24 and spacer pad 22. Further, as shown in FIG. 1, the front pad 24 hassubstantially the same thickness as that of the spacer pad 22. Ofcourse, the two pads may have unequal thicknesses depending on the needsof a particular application. In addition, the front pad may also beformed of rubber foam material. A thin layer of a plastic or urethanefilm 26 is then laid over the front pad 24. Adhesive material is used tohold the thin film 26 over the front pad 24. With the vacuum pumps 16being turned on, air will be sucked out of chamber 14 through channel18. The displaced volume of air is replaced by the streams of air thatflow into chamber 14 through the holes 21 extending through theperforated plate 20 adjacent the edges of the gel opening. The suctionof air through openings 21 into chamber 14 causes the thin film 26 to befirmly drawn into contact with perforated plate 20 and conform to theinner walls of spacer pad 22 and front pad 24.

A heating device is then used to heat the thin film 26 so that thin film26 will readily conform to the shape of the perforated base plate aswell as to the inner walls of spacer pad 22 and front pad 24. Gel-space27 is formed by substantially conforming the thin film 26 to the shapeof perforated base plate and the inner walls of front pad 24 and spacerpad 22. The vacuum pump 16 may continue to run in order to keep the thinfilm 26 in place. With thin film 26 kept tightly in place, apredetermined amount of liquid gel is then poured into the gel-space 27to substantially fill up the gel-space. (See FIG. 2). The liquid gel isallowed to cool off to form a semi-solid and resilient gel pad layer.

FIG. 2 is a partial cross-sectional side view of apparatus 12 of FIG. 1further illustrating the relative position of the gel pad with respectto the rest of the assembly. As shown in FIG. 2, the gel layer 28substantially fills up the gel space 27. When the gel layer 28solidifies within a short period of time, the depth of the gel layer 28is substantially equal to the total thickness of spacer pad 22 and frontpad 24. Then, the back pad 30 which may have adhesive material spreadover its bottom surface, may be overlaid onto the thin film 26 and gellayer 28. The adhesive material causes the back pad 30 to firmly adhereto the urethane layer 26, sealing the gel material in the product formedby the urethane film and the back pad. At this point, the process offorming gel pads is substantially completed.

At this stage, the assembly includes multiple layers, namely, the backpad layer 30, the gel layer 28, the front pad layer 24, the urethanelayer 26, and the spacer pad, 22. All layers except for the spacer padlayer 22 are confined or tightly held together using adhesive material.More specifically, the front pad is adhesively secured to the urethanelayer on one side of the urethane layer, and the back pad is adhesivelysecured to the other side of the urethane layer. Further, the semi-solidlayer of gel 28 is confined between the urethane layer 26 on one sideand to the back pad 30 on the other side. The spacer pad 22 is notconnected to any of the other layers and may be left behind when theremainder of the assembly is lifted up, after the vacuum is released.The purpose of spacer pad 22 was to help form the gel-pocket for formingof the gel pad.

FIG. 3 is a top view of the intermediate product 50 that includes threecontiguous units of gel pads. As shown in FIG. 3, three gel cushionpads, namely, cushion pads 34, 36 and 38 have been formed by the processdescribed above. Obviously, the number of the contiguous gel pads may beincreased by including more patterned openings on the surface of thespacer and front pads. Further, the pattern may be varied according tothe needs of a particular .application. The next step involves cuttingout each individual unit so that they may be used individually in awalking brace. (See FIG. 4).

FIG. 4 is a top view of an individual gel liner unit 44 after it hasbeen cut out of the composite pad 50 of FIG. 3. As shown in FIG. 4, thegel pad 42 is laterally enclosed by the inner walls of front aperturepad 40. With spacer pad 22 removed from the surface of unit 44, thesurface of the gel layer 42 extends beyond the surface of front pad 40.This is better shown in FIGS. 5 and 6.

FIG. 5 is a cross-sectional view of the gel liner 44, viewed along thelines V--V of FIG. 4, illustrating the back pad 46, front aperture pad40, and the semisolid gel layer 42. As clearly shown in FIG. 5, the gellayer 42 is thicker than from pad 40, as a result of the use of thespacer pad. This provides for a more efficient and comfortable gel padthat easily conforms to the shape of the ankle for a firm and resilientsupport of the injured ankle. These individual units of gel linen mayeasily be used in a walking brace 52 as shown in FIG. 7. Further, aportion of the gel pad 42 is laterally enclosed by the inner walls ofthe from aperture pad, to provide increased strength to the assembly.This is better shown in FIG. 6 of the drawings.

FIG. 6 is a side view of the gel liner 44 of FIG. 5, furtherillustrating the relative position of the different layers of the gelliner 44. As shown, a portion of the gel pad 42 is laterally confined bythe inner walls of the front pad 40.

FIG. 7 is an exploded view of a walking brace 52 illustrating the mannerin which the individual units of gel liners 44 and 54 are used inwalking brace 52. Each of the gel pads 44 or 54 are used to provide fora resilient support against the ankle on each side of the leg. Gel liner54 may be attached to the support wall 64 using velcro type material orother similar means. Similarly, gel liner 44 may be attached to thesupport wall 48 using .[.Velcro.]. .Iadd.VELCRO .Iaddend.type materialor other similar means. As is known in the art, .[.VELCRO typematerial.]. .Iadd.hook and loop material, such as VELCRO,.Iaddend.includes one pad having a series of very small hooks mounted onits surface, and another mating pad having loops or similar fabricconfiguration on its surface, in which the loops may engage. The two gelpads 44 and 54 and the stiff support walls 48 and 64 each have twomatching Velcro pads, see pads 65 and 67 on support wall 64, and pads 69and 71 on gel pad unit 44. The gel pad units and the support walls mayalso have oppositely paired VELCRO pads at their top and bottom so thatthe gel pads may not be mounted on the side walls upside down.

To further support the leg, a U-shaped stirrup member 80 is used.Stirrup member 80 includes a base plate or pad member 66 and straps 74and 76. The base plate or pad member 66 extends underneath the heel ofthe user. The straps 74 and 76 are used for firmly attaching the baseplate 66 to the side wall supports 64 and 48, respectively. Thus, forexample, strap 76 extends in and out of slots 73 and 75, respectivelyand engages .[.Velcro.]. .Iadd.VELCRO .Iaddend.pad 77.

The side support walls 48 and 64 may better support the leg when acounter strap 72 is used just above the heel to further limit the sidewails 64 and 48 from moving outward relative to the ankle. In addition,the bottom portion of the side wails 48 and 64 may be inserted in ashoe. With the bottom portion of the walking brace inserted in the shoe,the lace fastening loops 82 and 84 my be used to tightly secure thebrace on the foot in the ankle area. This is done by passing the shoelace through the D-shaped loop members 82 and 84 and then bringing theshoe laces back to the front and tying them together.

FIG. 8 illustrates the manner in which the walking brace is put on, withthe gel pads providing a comfortable, firm and resilient support againstthe ankle. As shown, the liners 52 and 44 substantially conform to theshape of the leg. Further, the side support wails 64 and 48 provide fora firm support against the leg. The straps 68 and 70 are used to firmlyhold the walking brace around the leg. This is better shown in FIG. 9.

FIG. 9 illustrates the manner in which a walking brace is secured. Asshown, the upper pan of the leg is firmly supported using the straps 68and 70. The mid and lower portion of the leg is supported by strap 70and counter strap 72. The lower portion of the leg is supported by thecounter strap 72 and lace members 82, 84, and the U-shaped stirrupmember 80.

The pad shown in FIG. 10 is similar to that shown and describedhereinabove in connection with FIGS. 4 through 7. More specifically, thepad of FIGS. 10 and 11 includes a foam rubber backing pad 102, a centralgel pad 104, and a peripheral layer of foam 106 which essentially merelyforms an enclosing rim, following cutting from a larger sheet. Inaddition, it may be noted that the gel pad 104 includes a recess 108 inthe vicinity of the ankle bone, or malleolus. In addition, a thinpolyurethane film 110 extends over the lower surface of the gel pad 104,as shown in FIG. 11, and is bonded to the backing layer 102 and to theperipheral foam layer 106. In order to form the recess 108, a smallrounded member may be placed on the apertured plate 20, as shown inFIGS. 1 and 2, in the proper location, to form the desired recess, asthe urethane film is laid over the apertured layers in the mannerdiscussed hereinabove.

FIGS. 12, 13, and 14 disclose the use of a gel pad assembly 122 which isshown as providing heat or cold therapy to the back of a person's neck,see particularly FIG. 14. In FIG. 14, the gel pad 122 is held in placeby a neck restraint 124 which extends around a person's neck, and isheld by suitable interfitting VELCRO pads, at the throat. As well asproviding additional restraint, the pad 122 my be employed to providehot or cold therapy, as may be advised by a doctor. Hot therapy may beachieved by heating the gel pad 122 in a microwave oven for a fewseconds, to the desired temperature; and cold therapy may beaccomplished by precooling the unit 122 in a refrigerator or freezer.

As shown to advantage in FIG. 13, taken along line 13--13 of FIG. 12,the assembly 122 includes a backing layer 126 of a thin film ofpolyurethane material, and a front layer 128 also of urethane film,bonded to the rear layer 126 along the periphery 130 of the unit, andalso at areas, such as the area 132, between adjacent gel pad areas 134and 136, for example. As shown in FIG. 12, the pad 122 also includesadditional gel pad zones 138, 140, 142, and 144.

If desired, the assembly 122 may be provided with a Velcro pad 152 whichmay make mating engagement with a mating .[.Velcro.]. .Iadd.VELCRO.Iaddend.pad on the central rear area of the neck brace 124. The VELCROpad 152 is preferably of the hook type, while the mating pad on the neckbrace 124 may be of the loop type, which is relatively soft, and whichwill not cause discomfort, if the neck brace 124 is employed without theadditional gel pad supporting member 122.

The gel pad member 122 may be fabricated using the apertured plate andvacuum arrangements of FIGS. 1 and 2, and employing a ridged spacermember, such as the member 22 shown in FIGS. 1 and 2, but formed toprovide the recessed areas, such as the area 132 which separates thevarious gel pad areas, as shown in FIGS. 12 and 13. With this type ofrecessed configuration, the assembly 122 may readily have its outeredges bent up out of the plane of the paper, in the showing of FIG. 12,so that it will easily fit around the neck and the back of the head, asshown in FIG. 14.

Accordingly, it may be seen that the use of the urethane layer, incombination with the gel pad, gives considerable advantages andflexibility in the formation of the gel pad to the desiredconfiguration. This advantage is in addition to its supplementalfunctions of avoiding undesired flow of the gel onto the patient; andconversely, the urethane layer prevents contamination of the gelincluded in the medical orthopaedic product.

The gel used in the implementation of the present invention ispreferably of the type sold under the trademark ELASTO-GEL, by SouthwestTechnologies, Inc. of Kansas City, Mo. Attention is also directed toEdward I. Stout, U.S. Pat. No. 4,671,267, granted Aug. 1, 1986, whichdiscloses the method for making the gel. In practice, the gel is mixedin liquid form and must be poured promptly into the pockets 27 forreceiving gel as shown in FIG. 1 of the drawings, where it hardens to asemi-solid state within about 1 to 5 minutes.

Concerning dimensions, the gel pad assemblies as shown in FIGS. 4, 5 and6 may be in the order of ten or eleven inches in length and about 3 andone-half to 4 and one-half inches in width. The actual gel portion ofthe pad may be about three inches in width and about five inches inlength. The pad unit as a whole is about one-quarter inch thick, withthe gel portion protruding by about one-sixteenth inch. In oneembodiment, the gel pad extends over most of the area of the unit ofFIGS. 4, 5 and 6, with the front layer only forming a rim aboutone-quarter to one-half inch wide around the periphery. In anotherembodiment, no foam rubber layers were present in the unit; instead, athicker spacer layer having a larger size opening was used, and aurethane film was used for the backing sheet. The resultant gel pad wassimilar in its overall configuration to the pads shown in my copendingpatent application cited hereinabove.

Concerning the gel pads, the combination of the inner gel pads and outerstiff supporting members, such as the plastic supports 48 and 64, oraluminum splinting stays, for example, has certain unique advantages.Specifically, these advantages include:

1. Hot and cold therapy resulting from the high specific heat or thermalcapacity of the gel, and its resultant quality of being able to supplyheat or cooling to an injured member, by pre-heating or precooling thegel pad, before application.

2. Conformation of the gel pad to the user's bodily configuration. Thegel pad has semi-solid gel which becomes deformed during use, andretains its deformed configuration to a substantial extent. Thus when auser takes the brace off, and then uses it again, putting it back on theankle, wrist, or other pan of the anatomy, the gel pad already conformssubstantially to the shape of the anatomy and an immediate comfortablefit results.

3. The gel pad is self-sealing as compared with air-inflatable cushionarrangements, so that injury from the stiff supporting members cuttingor rubbing the user, cannot occur.

4. The gel is not U.V. sensitive, and therefore does not deterioratewhen subject to prolonged U.V. exposure.

It is noted in passing that the invention is not limited to theembodiment shown in the drawings or to the foregoing detaileddescription. By way of example and not of limitation, the spacer pad,front pad, and back pad may be made of flexible foam rubber material, orother flexible material. Alternatively, the spacer pad may be made ofsolid and inflexible material. The thickness of these pads may berelatively small, for example 3 millimeters. The thickness of the threepads may be substantial equal or may be different. The back pad or rearclosure may be very thin and made of flexible material. For example, thebacking layer may be made of a thin plastic film, such as the urethanefilm 26, and the two urethane films may then be heat bonded oradhesively sealed to one-another to confine the gel. When the gel pad isconfined by urethane film, front and back, a thicker spacer pad may beused so that the gel pad remains fairly thick, and may have no frontpad. Apertures may have various patterns to meet the needs of aparticular application. The apertures may have a definite geometricalshape, for example, a rectangular shape, a horseshoe shape, or they mayhave curved boundaries to match the desired orthopaedic soft goodsapplication. The thin film may be made of urethane or other suitablethin and flexible material. The vacuum chamber may be wooden, plastic ormay be made of other suitable material. The holes on the perforated baseplate may be substantially equal in size ranging from less than one tomore than five millimeters in diameter. The holes may have unevendiameter sizes. Further, the holes may be evenly distributed throughoutthe base plate, or preferably, they may outline the inner edge of thespacer pad openings, with different perforated base plates beingemployed for differently shaped gel pads. The pattern on the surface ofeach of the pads may vary according to particular needs of anapplication.

What is claimed is:
 1. A reusable orthopaedic brace or supportcomprising:a gel pad assembly including a layer of gel; said gel padassembly having an impervious thin front plastic film directly engagingand confining the gel in said gel pad assembly, for preventingcontamination thereof and for preventing flow of said gel onto the user;a backing layer extending across the rear of said gel, to confine saidgel, and to prevent contamination thereof, said front plastic film beingpermanently bonded to said backing layer, orthopaedic support means forholding said gel pad assembly against a portion of the anatomy of auser; said plastic film defining the shape of the gel layer of said gelpad assembly and the thickness of the gel relative to said backinglayer; said gel pad assembly having a forwardly extending front surfacewhich is formed of relatively flat gel material covered by said plasticfilm, and said assembly having other areas facing in the same directionas said front surface which are recessed back from said front surface;said assembly permanently sealing the gel between the impervious frontplastic film and the backing layer; and a peripheral enclosing aperturepad secured to said backing layer and extending around and enclosing thesides of the gel, while the gel and said plastic film extend forwardfrom a plane defined by the front surface of said aperture pad.
 2. Anorthopaedic brace or support assembly as defined in claim 1 wherein saidbacking layer is formed of a sheet of foam rubber.
 3. A reusable anklebrace for insertion into a shoe for immobilizing the ankle againstinversion and eversion while permitting planter-flexion anddorsi-flexion, comprising:a pair of stiff side supports for fittingabout the lower leg on both sides; said side supports having aconfiguration to encompass both sides of the ankle, with the lower endof the side supports for insertion into the sides of the shoe; a pair ofliner members including a layer of dense gel for conforming to the shapeof the ankle and for providing a resilient support against the ankle;each said liner member including an apertured front pad having apatterned opening, an impervious thin film, a resilient backing pad, asemi-solid gel layer enclosed between said backing pad and said thinfilm, adhesive means for holding said thin film, said front pad, andsaid backing pad firmly and permanently together with said gel layerpermanently enclosed between said thin film and said backing layer;means for securing each said liner member to each said side supportwall; and means for securing said side supports to firmly encase theankle, said means including a counter strap extending between said sidesupports at a position just above the heel, said means also including aU-shaped stirrup member for providing a tighter grip about the lowerportion of the leg; said means also including at least one strapextending between said side supports for firmly encasing and supportingthe top and middle portion of the leg.
 4. An apparatus as defined inclaim 3 wherein said front pad and said backing pad each include a layerof foam rubber.
 5. An apparatus as defined in claim 3 wherein saidbacking pad includes a thin layer of urethane.
 6. A reusable orthopaedicbrace or support comprising:a gel pad assembly including a layer of gel;said gel pad assembly having an impervious front plastic film forconfining the gel in said gel pad assembly, for preventing contaminationthereof and for preventing flow of said gel onto the user; a backinglayer extending across the rear of said gel, to confine said gel, and toprevent contamination thereof, said front plastic film being permanentlybonded to said backing layer, said plastic film defining the shape ofthe gel layer of said gel pad assembly and the thickness of the gelrelative to said backing layer; said gel pad assembly having a forwardlyextending front surface which is formed of relatively flat gel materialcovered by said plastic film, and said assembly having other areasfacing in the same direction as said front surface which are recessedback from said front surface; said gel layer being formed into aplurality of zones by the engagement of said film with said backinglayer; and orthopaedic support means for holding said gel pad assemblyagainst the back of a person's neck to preclude excessive movement ofthe head.
 7. A reusable orthopaedic brace or support including a gel padassembly comprising:a first continuous substantially flay backing foamsheet member; a second substantially flat foam sheet member having anopening through it; a layer of gel mounted in said opening and extendingoutwardly away from said two foam sheet members; a thin impervious filmof sheet material extending over the outwardly extending gel layer, andsaid film extending in through the opening around the periphery of thegel layer to confine it, while facilitating heat flow between the gellayer and the body of a user; means for permanently securing said twofoam layers together and to said thin film to form a resilient gel padassembly with said gel layer covered by said impervious thin filmprotruding outwardly from the two foam layers and from said assembly;and support means for holding said gel pad assembly against a portion ofthe body of the user and for limiting movement of the body of the user.8. An orthopaedic brace for support as defined in claim 7 wherein theouter edges of said thin film are permanently secured in place betweensaid two foam sheet members.
 9. A reusable orthopaedic brace or supportcomprising:a gel pad assembly including a layer of gel; said gel padassembly having an impervious thin front plastic film directly engagingand confining the gel in said gel pad assembly, for preventingcontamination thereof and for preventing flow of said gel onto the user;a backing layer extending across the rear of said gel, to confine saidgel, and to prevent contamination thereof, said front plastic film beingpermanently bonded to said backing layer, orthopaedic support means forholding said gel pad assembly against a portion of the anatomy of auser; said plastic film defining the shape of the gel layer of said gelpad assembly and the thickness of the gel relative to said backinglayer; said gel pad assembly having a forwardly extending front surfacewhich is formed of relatively flat gel material covered by said plasticfilm, and said assembly having other areas facing in the same directionas said front surface which are recessed back from said front surface;said assembly permanently sealing the gel between the impervious frontplastic film and the backing layer; said gel pad assembly including twoseparate gel pads; and means including two stiff plastic members forholding said gel pads against the inner and outer sides of a patient'sankle.
 10. A reusable orthopaedic brace or support comprising:a gel padassembly including a layer of gel; said gel pad assembly having animpervious thin front plastic film for confining the gel in said gel padassembly, for preventing contamination thereof and for preventing flowof said gel onto the user; a backing layer extending across the rear ofsaid gel, to confine said gel, and to prevent contamination thereof,said front plastic film being permanently bonded to said backing layer,orthopaedic support means for holding said gel pad assembly against aportion of the anatomy of a user; said plastic film defining the shapeof the gel layer of said gel pad assembly and the thickness of the gelrelative to said backing layer, and permanently confining said gelbetween said film and said backing layer; and a peripheral enclosingaperture pad secured to said backing layer and extending around andenclosing the sides of the gel, while the gel and said plastic filmextend forward from a plane defined by the front surface of saidaperture pad.
 11. A reusable orthopaedic brace or support comprising:agel pad assembly including a layer of gel; said gel pad assembly havingan impervious thin front plastic film for confining the gel in said gelpad assembly, for preventing contamination thereof and for preventingflow of said gel onto the user; a backing layer extending across therear of said gel, to confine said gel, and to prevent contaminationthereof, said front plastic film being permanently bonded to saidbacking layer, orthopaedic support means for holding said gel padassembly against a portion of the anatomy of a user; said plastic filmdefining the shape of the gel layer of said gel pad assembly and thethickness of the gel relative to said backing layer, and permanentlyconfining said gel between said film and said backing layer; said gelpad assembly including two separate gel pads; and means including twostiff plastic members for holding said gel pads against the inner andouter sides of a patient's ankle.
 12. A reusable orthopaedic brace orsupport comprising:a resilient substantially flat backing sheet; anapertured front pad; a substantially flat semi-solid gel pad layermounted in the aperture in said front pad and protruding forward andaway from said backing sheet and front pad; a substantially imperviousthin film adhesively and permanently secured between said backing sheetand said front pad and extending over the front of said gel pad layer;stiff orthopaedic support means for holding said gel pads in engagementwith a portion of a patient's body; said stiff support means includestwo relatively movable parts; and removable securing means includingstrap means for firmly holding said two relatively movable partstogether. .Iadd.
 13. A reusable orthopaedic brace or support assemblycomprising:an orthopaedic support for extending around an injuredportion of a user's body; means including a gel pad for applying hot andcold therapy to the injured portion of the user's body; said gel padhaving an impervious thin front plastic film means directly engaging andconfining the gel within said gel pad, for preventing contaminationthereof, for preventing flow of said gel onto the user, and forfacilitating heat transfer for said hot and cold therapy; a backinglayer extending across the rear of said gel, to confine said gel, and toprevent contamination thereof, said front plastic film means beingsecured to said backing layer; quick release securing means for holdingsaid pads onto said orthopaedic support; said orthopaedic support havinga configuration conforming to the irregular configuration of the portionof the user's body to which the assembly is being applied; and means forholding said orthopaedic support and said gel pad firmly onto theinjured portion of the user's body; whereby the injured portion of theuser's body may be concurrently provided with support and said hot andcold therapy, with the gel pads pressed against the injuredportion..Iaddend. .Iadd.
 14. A reusable orthopaedic brace or supportcomprising:a gel pad assembly including a layer of gel for providing hotand cold therapy; said gel pad assembly having an impervious thin frontplastic film means for confining the gel in said gel pad assembly, forpreventing contamination thereof, for preventing flow of said gel ontothe user, and for facilitating heat transfer for said hot and coldtherapy; a backing layer extending across the rear of said gel, toconfine said gel, and to prevent contamination thereof, said frontplastic film means being permanently bonded to said backing layer; andorthopaedic support means for holding said gel pad assembly against aportion of a user's body..Iaddend. .Iadd.
 15. A reusable orthopaedicbrace or support as defined in claim 14, further including quick releasesecuring means for holding said pads onto said orthopaedicsupport..Iaddend. .Iadd.16. A reusable orthopaedic brace or support asdefined in claim 14, in which the orthopaedic support has aconfiguration conforming to the irregular configuration of the portionof the user's body to which the assembly is being applied..Iaddend..Iadd. A reusable orthopaedic brace or support comprising:a gel padassembly including a layer of gel for providing hot and cold therapy;said gel pad assembly having an impervious thin front plastic film forconfining the gel in said gel pad assembly, for preventing contaminationthereof, for preventing flow of said gel onto the user, and forfacilitating heat transfer for said hot and cold therapy; a backinglayer extending across the rear of said gel, to confine said gel, and toprevent contamination thereof, said front plastic film being permanentlybonded to said backing layer; orthopaedic support means for holding saidgel pad assembly against a portion of a user's body; and quick releasesecuring means for holding said pads onto said orthopaedic support; inwhich the orthopaedic support has a configuration conforming to theirregular configuration of the portion of the user's body to which theassembly is being applied..Iaddend. .Iadd.18. An orthopaedic brace orsupport assembly, comprising:a gel pad assembly including (1) a body ofgel adapted to provide hot and cold therapy too an injured portion of auser's body, (2) an impervious thin front film which extends across afront of said body of gel, which prevents flow of the gel of said bodyof gel onto the user and which facilitates the transfer of therapeuticheat and cold from said body of gel to the injured portion, and (3) abacking layer extending across a rear of said body of gel and secured tosaid front film to thereby confine and protect said body of gel; andorthopaedic support means for holding said gel pad assembly with saidfront film generally against the injured portion such that hot and coldtherapy can be applied to the injured portion..Iaddend. .Iadd.19. Anapparatus as defined in claim 18 wherein said front film is constructedof plastic and is permanently sealed to said backing layer..Iaddend..Iadd.20. An apparatus as defined in claim 18 wherein said backing layeris constructed so to resiliently support the injured portion and tothermally insulate the rear of said body of gel..Iaddend. .Iadd.21. Anapparatus as defined in claim 18 wherein said orthopaedic support meansincludes a support member configured to conform to the irregularconfiguration of the part of the user to which said apparatus is beingapplied..Iaddend. .Iadd.22. An apparatus as defined in claim 18 whereinsaid front film permits configuration of said body of gel to a contourof the injured portion..Iaddend. .Iadd.23. An apparatus as defined inclaim 18 wherein said front film is formed of urethane..Iaddend..Iadd.24. An apparatus as defined in claim 18 wherein said gel padassembly self seals after a puncture thereto..Iaddend. .Iadd.25. Anapparatus as defined in claim 18 wherein said body of gel includes asemi-solid gel which deforms during use against the injured portion andretains its deformed configuration to a substantial extent after removalfrom the injured portion such that said assembly is reusablethereon..Iaddend. .Iadd.26. An apparatus as defined in claim 18 furthercomprising quick release securing means for releasably securing said gelpad assembly to said orthopaedic support means..Iaddend.